MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-27 for STATSTRIP GLUCOSE HOSPITAL METER SYSTEM 54794 54790 manufactured by Nova Biomedical Corp..
| Report Number | 1219029-2019-00041 |
| MDR Report Key | 8935507 |
| Date Received | 2019-08-27 |
| Date of Report | 2019-08-27 |
| Date of Event | 2019-07-25 |
| Date Mfgr Received | 2019-07-31 |
| Date Added to Maude | 2019-08-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TAYLOR WARD |
| Manufacturer Street | 200 PROSPECT ST |
| Manufacturer City | WALTHAM MA 024543465 |
| Manufacturer Country | US |
| Manufacturer Postal | 024543465 |
| Manufacturer Phone | 7816473700 |
| Manufacturer G1 | NOVA BIOMEDICAL CORP. |
| Manufacturer Street | 200 PROSPECT ST |
| Manufacturer City | WALTHAM MA 024543465 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 024543465 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM |
| Generic Name | GLUCOSE TEST SYSTEM |
| Product Code | PZI |
| Date Received | 2019-08-27 |
| Returned To Mfg | 2019-08-21 |
| Model Number | 54794 |
| Catalog Number | 54790 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVA BIOMEDICAL CORP. |
| Manufacturer Address | 200 PROSPECT ST WALTHAM MA 024543465 US 024543465 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-27 |